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United States Government Accountability Office: 
GAO: 

Report to Congressional Requesters: 

May 2011: 

VA Health Care: 

Weaknesses in Policies and Oversight Governing Medical Supplies and 
Equipment Pose Risks to Veterans' Safety: 

GAO-11-391: 

GAO Highlights: 

Highlights of GAO-11-391, a report to congressional requesters. 

Why GAO Did This Study: 

Department of Veterans Affairs (VA) clinicians use expendable medical 
supplies—disposable items that are generally used one time—and 
reusable medical equipment (RME), which is designed to be reused for 
multiple patients. VA has policies that VA medical centers (VAMC) must 
follow when purchasing such supplies and equipment, tracking these 
items at VAMCs, and reprocessing-—that is, cleaning, disinfecting, and 
sterilizing—-RME. GAO was asked to evaluate (1) purchasing, tracking, 
and reprocessing requirements in VA policies and (2) VA’s oversight of 
VAMCs’ compliance with these requirements. GAO reviewed VA policies 
and selected two purchasing requirements, two tracking requirements, 
and two reprocessing requirements. At the six VAMCs GAO visited, GAO 
interviewed officials and reviewed documents to examine the adequacy 
of the selected requirements to help ensure veterans’ safety. GAO also 
interviewed officials from VA headquarters and from six Veterans 
Integrated Service Networks (VISN), which oversee VAMCs, and obtained 
and reviewed documents regarding VA’s oversight. 

What GAO Found: 

GAO found that the VA tracking and reprocessing requirements selected 
for review are inadequate to help ensure the safety of veterans who 
receive care at VAMCs. GAO did not identify inadequacies in selected 
VA purchasing requirements that may create potential risks to veterans’
safety. GAO found the following: 

* Tracking requirements. Because VA does not require VAMCs to enter 
information about certain expendable medical supplies and RME in their 
facilities into VA’s inventory management systems, VAMCs may have 
incomplete inventories of these items. This, in turn, creates 
potential risks to veterans’ safety. For example, in the event of a 
manufacturer recall involving these items, VAMCs may be unable to 
readily determine whether the items are in their facilities and should 
be removed and not used when providing care to veterans. 

* Reprocessing requirements. Although VA requires VAMCs to develop 
device-specific training for staff on how to correctly reprocess RME, 
VA has not specified the types of RME for which this training is 
required. VA has also provided conflicting guidance to VAMCs on how to 
develop this training. This lack of clarity may have contributed to 
delays in developing the required training. Without appropriate 
training on reprocessing, VAMC staff may not be reprocessing RME 
correctly, which poses potential risks to the safety of veterans. VA 
headquarters officials told GAO that VA has plans to develop training 
for certain RME, but VA lacks a timeline for developing this training. 

GAO also found weaknesses in VA’s oversight of VAMCs’ compliance with 
the selected purchasing and reprocessing requirements. These 
weaknesses render VA unable to systematically identify and address 
noncompliance with the requirements, which poses potential risks to 
the safety of veterans. GAO did not identify weaknesses in VA’s 
oversight of VAMCs’ compliance with the selected tracking 
requirements. GAO found the following: 

* Oversight over purchasing requirements. In general, VA does not 
oversee VAMCs’ compliance with the selected purchasing requirements. 
While VA intends to improve oversight over these requirements, it has 
not yet developed a plan for doing so. 

* Oversight over reprocessing requirements. Although VA headquarters 
receives information from the VISNs on any noncompliance they identify 
as well as VAMCs’ corrective action plans to address this 
noncompliance, VA headquarters does not analyze this information to 
inform its oversight. According to VA headquarters officials, VA 
intends to develop a plan for analyzing this information to 
systematically identify areas of noncompliance that occur frequently, 
pose high risks to veterans’ safety, or have not been addressed across 
all VAMCs. 

What GAO Recommends: 

GAO is making several recommendations for VA to address the 
inadequacies identified in selected tracking and reprocessing 
requirements and the weaknesses in its oversight over selected 
purchasing and reprocessing requirements. VA concurred with these 
recommendations. 

View [hyperlink, http://www.gao.gov/products/GAO-11-391] or key 
components. For more information, contact Randall B. Williamson at 
(202) 512-7114 or williamsonr@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

Selected VA Requirements for Tracking and Reprocessing Are Inadequate 
to Help Ensure Veterans' Safety: 

VA's Oversight of VAMCs' Compliance with Selected Purchasing and 
Reprocessing Requirements Has Weaknesses: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Scope and Methodology: 

Appendix II: Comments from the Department of Veterans Affairs: 

Appendix III: GAO Contact and Staff Acknowledgments: 

Table: 

Table 1: Characteristics of VAMCs Selected for Site Visits: 

Figure: 

Figure 1: Selected Veterans Affairs (VA) Entities' Roles and 
Responsibilities for Purchasing, Tracking, and Reprocessing: 

Abbreviations: 

AEMS/MERS: Automated Engineering Management System/Medical Equipment 
Reporting System 

GIP: Generic Inventory Package: 

HIV: Human Immunodeficiency Virus: 

MQAS: Management Quality Assurance Service: 

OIG: Office of Inspector General: 

RME: reusable medical equipment: 

SOP: standard operating procedure: 

SPD: Supply, Processing, and Distribution: 

VA: Department of Veterans Affairs: 

VAMC: Veterans Affairs medical center: 

VHA: Veterans Health Administration: 

VISN: Veterans Integrated Service Network: 

[End of section] 

United States Government Accountability Office: 
Washington, DC 20548: 

May 3, 2011: 

The Honorable Jeff Miller: 
Chairman: 
The Honorable Bob Filner: 
Ranking Member: 
Committee on Veterans' Affairs: 
House of Representatives: 

The Honorable Charles E. Grassley: 
United States Senate: 

The Honorable Russ Carnahan: 
House of Representatives: 

The Department of Veterans Affairs (VA) operates one of the largest 
integrated health care delivery systems in the United States, 
providing care to over 5.5 million veterans annually. Organized into 
21 Veterans Integrated Service Networks (VISN), VA's health care 
system includes 153 VA medical centers (VAMC) nationwide that offer a 
variety of outpatient, residential, and inpatient services.[Footnote 
1] In providing health care services to veterans, clinicians at VAMCs 
use supplies and equipment purchased by VA. These include expendable 
medical supplies, such as needles and scalpel blades, which are 
generally used once and discarded, and reusable medical equipment 
(RME), which is designed to be reused for multiple patients and 
includes such equipment as endoscopes and some surgical instruments. 
Because RME is used when providing care to multiple veterans, this 
equipment must be reprocessed--that is, cleaned and disinfected or 
sterilized--between uses. VA has established requirements for VAMCs to 
follow for purchasing items such as expendable medical supplies and 
RME; for tracking--that is, accounting for--these items at their 
facilities;[Footnote 2] and for reprocessing RME.[Footnote 3] These 
policies are designed, in part, to help ensure the safety of the 
veterans who receive care at VAMCs. 

Recent press articles have reported lapses in compliance with VA's 
reprocessing requirements at some VA medical centers, which may have 
put the safety of thousands of veterans receiving care at these 
facilities at risk.[Footnote 4] For example, one article reported that 
between 2009 and 2010, about 1,800 veterans were potentially exposed 
to infectious diseases at the St. Louis VAMC, because they received 
care using improperly reprocessed dental instruments.[Footnote 5] 
Moreover, in a September 2010 congressional hearing, we presented our 
preliminary observations on veterans' safety issues related to 
expendable medical supplies and RME. We reported examples of 
noncompliance with VA's requirements for purchasing and tracking 
certain medical supplies and equipment, which may pose risks to 
veterans' safety. In response, a congressional committee and certain 
members of Congress have raised questions about the adequacy of VA's 
requirements for purchasing, tracking, and reprocessing to help ensure 
veterans' safety. In addition, questions have been raised regarding 
the adequacy of VA's oversight of VAMCs' compliance with these 
requirements. In this report, we examine (1) VA purchasing, tracking, 
and reprocessing requirements in VA policies, which were selected 
based on their relevance to patient safety incidents, and (2) VA's 
oversight of VAMCs' compliance with these selected requirements. 

To examine VA purchasing, tracking, and reprocessing requirements, we 
reviewed relevant VA policies, and from these policies we judgmentally 
selected two purchasing requirements, two tracking requirements, and 
two reprocessing requirements that we determined were relevant to 
patient safety incidents that were identified at certain VAMCs. 
[Footnote 6] After selecting these requirements for our review, we 
judgmentally selected six VAMCs from the following locations to visit: 
Albany, New York; Cheyenne, Wyoming; Detroit, Michigan; Miami, 
Florida; Palo Alto, California; and St. Louis, Missouri. These VAMCs 
represent different surgical complexity groups[Footnote 7] and 
geographic regions[Footnote 8] and serve veteran populations of 
different sizes. At these six VAMCs, we examined the adequacy of the 
selected purchasing, tracking, and reprocessing requirements to help 
the facilities ensure the safety of veterans who received care at 
these facilities. To do this, we examined how the selected 
requirements in these policies were implemented and whether or to what 
extent the selected requirements directly or indirectly created a 
potential risk to the safety of the veterans receiving care at the 
VAMCs. We reviewed applicable VAMC committee meeting minutes[Footnote 
9] and other documentation on the implementation of these 
requirements. We also interviewed VAMC officials who were responsible 
for implementing the selected requirements in VA policies to determine 
whether the selected requirements are adequate to help ensure 
veterans' safety. 

To examine VA's oversight of VAMCs' compliance with the purchasing, 
tracking, and reprocessing requirements we selected, we reviewed VA's 
oversight of these requirements and evaluated whether this oversight 
provides VA with adequate information to identify and address 
noncompliance. As part of this review, we assessed VA's oversight in 
the context of federal standards for internal control for monitoring. 
[Footnote 10] The internal control for monitoring refers to an 
agency's ability to assure that ongoing review and supervision 
activities are conducted, with the scope and frequency depending on 
the assessment of risks; deficiencies are communicated to at least one 
higher level of management; and actions are taken in response to 
findings or recommendations within established timelines. We 
interviewed officials responsible for overseeing VAMCs' compliance 
with the requirements we selected for review from VA headquarters, 
VA's Office of Inspector General (OIG), and six VISNs that are 
responsible for overseeing compliance at the VAMCs we visited. In 
addition, we obtained and reviewed relevant documents regarding VA 
oversight, including internal reports, VAMCs' plans to correct 
problems identified through oversight activities, and policy 
memorandums. 

We conducted this performance audit from March 2010 to May 2011 in 
accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives. See appendix I 
for more information on our scope and methodology. 

Background: 

VA is required by law to provide hospital care and medical services to 
certain veterans and may provide care to other veterans.[Footnote 11] 
In general, veterans must enroll in VA health care to receive VA's 
medical benefits package that includes a range of services such as 
preventative health care services and inpatient hospital services. 
Veterans may receive certain other health care services, such as 
dental care, without enrolling.[Footnote 12] VA provides these 
services at various types of facilities, including VAMCs. In providing 
these services to veterans, clinicians at VAMCs use expendable medical 
supplies and RME. VA has established roles and responsibilities within 
its system for purchasing, tracking, and reprocessing of these items 
and policies that VAMCs are required to follow when purchasing and 
tracking these items at their facilities. VA also has policies that 
VAMCs are required to follow regarding the reprocessing of RME. 

VA Roles and Responsibilities for Purchasing, Tracking, and 
Reprocessing: 

VA headquarters is responsible for the development of policies related 
to purchasing, tracking, and reprocessing and is ultimately 
responsible for ensuring that VISNs and VAMCs are in compliance with 
these policies. Within VA headquarters, the Office of Acquisition, 
Logistics, and Construction and the Procurement and Logistics Office, 
are responsible for policies related to the purchasing and tracking of 
expendable medical supplies and RME, while the Sterile Processing 
Department is responsible for policies related to the reprocessing of 
RME. 

Each of the 21 regional VISNs is responsible for ensuring compliance 
with VA's policies at the VAMCs within its region. VISNs report to the 
Deputy Under Secretary for Health for Operations and Management within 
VA headquarters. In turn, each of the 153 VAMCs is responsible for 
implementing VA's policies. Within each VAMC, the Acquisition 
Department is responsible for purchasing expendable medical supplies 
and RME, the Logistics Department is responsible for tracking these 
items, and the Sterile Processing Department is responsible for 
reprocessing RME. (See figure 1 for an overview of VA's organizational 
structure.) 

Figure 1: Selected Veterans Affairs (VA) Entities' Roles and 
Responsibilities for Purchasing, Tracking, and Reprocessing: 

[Refer to PDF for image: chart] 

VA Headquarters: 
VA headquarters is responsible for the development of policies, and 
for ensuring that Veterans Integrated Service Networks (VISN) and 
Veterans Affairs Medical Centers (VAMC) are in compliance with these 
policies. 

Top level: Secretary of VA. 
* Office of Acquisition, Logistics, and Construction[A]. 

Second level, reporting to Secretary of VA: 
* Deputy Under Secretary for Health for Operations and Management[A]. 

Reporting to Deputy Under Secretary for Health for Operations and 
Management: 
* Procurement and Logistics Office[A]; 
* Sterile Processing Department[A]. 

VISNs: 
There are 21 regional VISNs, each responsible for ensuring compliance 
with VA’s policies at the VAMCs within its region. 

VISN Director: Reports to VA Deputy Under Secretary for Health for 
Operations and Management. 

VAMCs: 
Each of the 153 VAMCs is responsible for implementing VA's policies. 

VAMC Director: Reports to VISN Director. 

Reporting to VAMC Director: 
* Logistics Department[A]; 
* Sterile Processing Department[A]. 

Reporting to VA Procurement and Logistics Office: 
* Acquisition Department[A]. 

Source: GAO. 

[A] Indirect reporting relationship. 

[End of figure] 

VA Policies for Purchasing, Tracking, and Reprocessing: 

VA policies specify how VAMCs can purchase expendable medical supplies 
and RME. VAMCs can purchase expendable medical supplies and RME 
through their acquisition departments or through their clinical 
departments, such as the radiology department. VA's policies include 
the following requirements related to veterans' safety that VAMCs must 
follow when purchasing expendable medical supplies and RME: 

Committee review and approval. A designated VAMC committee must review 
and approve proposed purchases of any expendable medical supplies or 
RME that have not been previously purchased by the VAMC.[Footnote 13] 
The committee, which typically includes administrative staff and 
clinicians from various departments, reviews the proposed purchases to 
evaluate the cost of the purchase as well as its likely effect on 
veterans' care.[Footnote 14] For example, the committee that reviews 
and approves proposed RME purchases often includes a representative 
from the department responsible for reprocessing RME in order to 
determine whether the VAMC has the capability to reprocess the item 
correctly and to ensure that staff are appropriately trained to do so. 
Proper reprocessing of RME is important to ensure that RME is safe to 
use and that veterans are not exposed to infectious diseases, such as 
Human Immunodeficiency Virus (HIV), during treatment. 

Signatures from two officials. All approvals for purchases of 
expendable medical supplies and RME must be signed by two officials, 
the official placing the order and the official responsible for 
approving the purchase.[Footnote 15] This process helps ensure that 
purchases of expendable medical supplies and RME are appropriate to 
use when providing care to veterans. 

VA has two inventory management systems that it requires VAMCs to use 
to track the type and quantity of expendable medical supplies and RME 
used in its facilities. VAMCs use information about the items in their 
facilities for a variety of purposes, for example to readily determine 
whether they have expendable medical supplies or RME that are the 
subject of a manufacturer recall or a patient safety alert. VA policy 
requires that each VAMC enter information about certain expendable 
medical supplies and RME in their facilities into the appropriate 
system. Specifically, VA policies include two key requirements related 
to veterans' safety that VAMCs must follow for tracking expendable 
medical supplies and RME: 

Tracking of expendable medical supplies. VAMCs must enter information 
on all expendable medical supplies that are ordered on a recurring 
basis into the Generic Inventory Package (GIP).[Footnote 16] 

Tracking of RME. VAMCs must enter information on all RME that is 
classified as nonexpendable equipment by VA's Office of Acquisition, 
Logistics, and Construction into the Automated Engineering Management 
System/Medical Equipment Reporting System (AEMS/MERS).[Footnote 17] 

VA policies include requirements designed to help ensure that VAMCs 
reprocess RME correctly,[Footnote 18] in order to help ensure that RME 
is safe for use when providing care to veterans. VA's reprocessing 
policies include two key types of requirements: 

Training requirements. To ensure that RME is reprocessed in accordance 
with manufacturers' guidelines, VA requires that each VAMC develop 
device-specific training for reprocessing RME. To develop this 
training, VA requires VAMCs to create device-specific standard 
operating procedures (SOP), which provide step-by-step instructions 
for reprocessing. VA also requires VAMCs to assess staff annually on 
their competence to reprocess RME in accordance with these SOPs. 

Operational requirements. To ensure that reprocessing activities are 
performed safely and that RME is reprocessed correctly, VA policies 
establish operational requirements for VAMCs, which include that VAMC 
staff must monitor sterilizers to ensure that they are functioning 
properly, use personal protective equipment when performing 
reprocessing activities, and segregate dirty and clean RME. 

Selected VA Requirements for Tracking and Reprocessing Are Inadequate 
to Help Ensure Veterans' Safety: 

We found that both the tracking and reprocessing requirements we 
reviewed are inadequate to help ensure the safety of veterans who 
receive care at VAMCs. These inadequacies create potential risks to 
the safety of veterans who receive care at VAMCs. However, we did not 
identify any inadequacies in the purchasing requirements we selected 
for review that may create potential risks to veterans' safety. 

VAMCs Are Not Required to Track Certain Expendable Medical Supplies 
and RME: 

VA does not require VAMCs to enter information about certain 
expendable medical supplies and RME into their inventory management 
systems, and therefore, VAMC inventories have incomplete information 
on these items. Specifically, VAMCs are not required to enter into GIP 
information on expendable medical supplies purchased on a nonrecurring 
basis. Furthermore, VAMCs are not required to enter into AEMS/MERS 
information on RME that VA's Office of Acquisition, Logistics, and 
Construction does not classify as nonexpendable equipment. RME that is 
not classified as nonexpendable equipment includes certain surgical 
and dental instruments. As a result, none of the six VAMCs we visited 
had complete inventories of all of the expendable medical supplies or 
RME in their facilities. Incomplete inventories of these items at 
VAMCs can pose potential risks to veterans' safety. 

At all six of the VAMCs we visited, we identified examples of 
potential risks to veterans' safety that may result from these 
inadequacies in VA's tracking requirements. For example: 

Limited ability to identify items on which there are alerts or 
recalls. In the event of a manufacturer recall or patient safety alert 
related to an expendable medical supply item or RME, VAMCs may be 
unable to use their inventory management systems to systematically 
determine whether the affected item is in their facilities and should 
therefore be removed so that it is not used when providing care to 
veterans. Rather, VAMC officials would have to rely on a physical 
search for the item throughout their facilities--and a physical search 
could miss items. As we reported in our 2010 testimony,[Footnote 19] 
VAMC officials and officials from the VA OIG told us that in response 
to a patient safety alert in December 2008 regarding an auxiliary 
water tube--a type of RME that is used with a colonoscope--VAMC 
officials checked their inventory management systems and concluded--
incorrectly--that the tube was not used in the facility.[Footnote 20] 
However, in March 2009, the VAMC discovered that the tube was in use 
in the facility and was not being reprocessed correctly, potentially 
exposing 2,526 veterans to infectious diseases such as HIV, hepatitis 
B, and hepatitis C.[Footnote 21] 

Difficulty maintaining appropriate inventories. Because GIP helps 
VAMCs to ensure that they maintain appropriate quantities of supply 
items in their facilities, VAMCs with incomplete information in GIP 
about the supplies in their facilities may have difficulty ensuring 
that they maintain appropriate quantities of these items. This may 
result in expendable medical supplies being unavailable for veterans' 
care if needed or, alternatively, excess supplies accumulating and 
expiring before they can be used. For example, in 2009 and 2010, VA 
headquarters officials identified expired expendable medical supplies, 
which were not being properly tracked in GIP, at three of the six 
VAMCs we visited. Had these VAMCs been properly tracking these supply 
items in GIP, they may have been able to maintain appropriate 
quantities of items and therefore avoid unavailable or expired 
supplies. 

Challenges developing required training. VAMCs with incomplete 
information about the RME in their inventories face challenges 
identifying the equipment for which they must develop device-specific 
reprocessing training. None of the six VAMCs we visited relied on 
their inventory management systems to systematically determine which 
types of RME they had in their facilities. In fact, officials at all 
six VAMCs told us that they had to use alternate methods, such as 
contacting individual staff members or conducting searches in each 
clinical department, to determine if the facility had a specific type 
of RME. These methods of searching for RME make it difficult for VAMCs 
to ensure that they identify all of the RME in their facilities for 
which they must develop device-specific reprocessing training--without 
inadvertently missing items--and may have contributed to delays in 
developing this training. Approximately 1 year after VA instituted the 
requirement for developing device-specific training for reprocessing, 
three of the six VAMCs we visited had not yet fully developed this 
training. Without appropriate training for reprocessing RME, VAMCs 
cannot ensure that staff in their facilities are reprocessing RME 
correctly so that these items are safe for use when caring for 
veterans. 

At the time of our review, VA did not have plans to immediately 
address the inadequacies we identified in the tracking requirements by 
requiring VAMCs to enter information about all expendable medical 
supplies and RME into VA's inventory management systems. VA 
headquarters officials told us that they plan to address the 
inadequacies we identified in the tracking requirements following 
implementation of a new inventory management system--Strategic Asset 
Management. However, VA had suspended the implementation of this 
system as of March 2011. Although VA did not plan on revising its 
tracking requirements immediately, officials from two of the six VAMCs 
we visited told us that they have taken steps to improve the 
information they maintain on the expendable medical supplies at their 
facilities. Officials told us that they are requiring staff to enter 
information about all expendable medical supplies at these VAMCs into 
GIP, including those that are purchased on a nonrecurring basis. 

Selected VA Reprocessing Requirements Are Inadequate: 

The VA reprocessing requirements we selected for review are inadequate 
to help ensure veterans' safety in two respects: (1) they do not 
specify the types of RME for which VAMCs must develop device-specific 
training, and (2) VA has provided VAMCs with conflicting guidance on 
how to develop this training.[Footnote 22] 

Lack of specificity about types of RME that require device-specific 
training. The VA reprocessing requirements we reviewed do not specify 
the types of RME for which VAMCs must develop device-specific 
training. This inadequacy has caused confusion among VAMCs and 
contributed to inconsistent implementation of training for RME 
reprocessing. While VA headquarters officials told us that the 
training requirement is intended to apply to RME classified as 
critical--such as surgical instruments--and semi-critical--such as 
certain endoscopes,[Footnote 23] officials from five of the six VAMCs 
we visited told us that they were unclear about the RME for which they 
were required to develop device-specific training. 

Officials at one VAMC we visited told us that they did not develop all 
of the required reprocessing training for critical RME--such as 
surgical instruments--because they did not understand that they were 
required to do so. Officials at another VAMC we visited also told us 
that they had begun to develop device-specific training for 
reprocessing non-critical RME, such as wheelchairs, even though they 
had not yet fully completed device-specific training for more critical 
RME. Because these two VAMCs had not developed the appropriate device- 
specific training for reprocessing critical and semi-critical RME, 
staff at these VAMCs may not have been reprocessing all RME properly, 
which potentially put the safety of veterans receiving care at these 
facilities at risk. 

Conflicting guidance on the development of RME reprocessing training. 
While VA requires VAMCs to develop device-specific training on 
reprocessing RME, VA headquarters officials provided VAMCs with 
conflicting guidance on how they should develop this training. For 
example, officials at three VAMCs we visited told us that certain VA 
headquarters or VISN officials stated that this device-specific 
training should very closely match manufacturer guidelines--in one 
case verbatim--while other VA headquarters or VISN officials stated 
that this training should be written in a way that could be easily 
understood by the personnel responsible for reprocessing the RME. This 
distinction is important, since VAMC officials told us that some of 
the staff responsible for reprocessing the RME may have difficulty 
following the more technical manufacturers' guidelines.[Footnote 24] 
In part because of VA's conflicting guidance, VAMC officials told us 
that they had difficulty developing the required device-specific 
training and had to rewrite the training materials multiple times for 
RME at their facilities. Officials at five of the six VAMCs also told 
us that developing the device-specific training for reprocessing RME 
was both time consuming and resource intensive. 

VA's lack of specificity and conflicting guidance regarding its 
requirement to develop device-specific training for reprocessing RME 
may have contributed to delays in developing this training at several 
of the VAMCs we visited. Officials from three of the six VAMCs told us 
that they had not completed the development of device-specific 
training for RME since VA established the training requirement in July 
2009. As of October 2010, 15 months after VA issued the policy 
containing this requirement, officials at one of the VAMCs we visited 
told us that device-specific training on reprocessing had not been 
developed for about 80 percent of the critical and semi-critical RME 
in use at the facility. 

VA headquarters officials told us that they are aware of the lack of 
specificity and conflicting guidance provided to VAMCs regarding the 
development of training for reprocessing RME, and were also aware of 
inefficiencies resulting from each VAMC developing its own training 
for reprocessing types of RME that are used in multiple VAMCs. In 
response, VA headquarters officials told us that they have made 
available to all VAMCS a database of standardized device-specific 
training developed by RME manufacturers for approximately 1,000 types 
of RME and plan to require VAMCs to implement this training by June 
2011. The officials also told us that VA headquarters is planning to 
develop device-specific training available to all VAMCs for certain 
critical and semi-critical RME for which RME manufacturers have not 
developed this training, such as dental instruments. However, as of 
February 2011, VA headquarters has not completed device-specific 
training for these RME and has not established plans or corresponding 
timelines for completing this training. 

VA's Oversight of VAMCs' Compliance with Selected Purchasing and 
Reprocessing Requirements Has Weaknesses: 

VA's oversight of VAMCs' compliance with selected purchasing and 
reprocessing requirements has weaknesses, which result in VA not being 
able to systematically identify and address noncompliance. We did not 
identify any weaknesses in VA's oversight of the tracking requirements 
we selected for review.[Footnote 25] Oversight of VAMCs' compliance 
with the selected purchasing, tracking, and reprocessing requirements 
is important because, at each of the six VAMCs we visited, we 
identified examples of noncompliance, which may result in risks to 
veterans' safety. VA headquarters officials told us that VA intends to 
improve oversight over the selected purchasing requirements, but has 
not yet developed a plan for doing so. In addition, VA recently made 
changes to its oversight of VAMCs' compliance with selected 
reprocessing requirements; however, this oversight continues to have 
weaknesses. 

VA Has Limited Oversight of VAMCs' Compliance with Selected Purchasing 
Requirements: 

We found that, in general, VA does not oversee VAMCs' compliance with 
the purchasing requirements we selected for review. Specifically, 
neither VA headquarters nor the six VISNs that oversee the VAMCs we 
visited provided oversight for the committee review and approval 
requirement and only one of the six VISNs provided oversight of the 
double signature requirement.[Footnote 26] Consistent with the federal 
internal control for monitoring, which is applicable to all federal 
agencies, we would expect VA to oversee VAMCs' compliance with the 
requirements we selected, assess the risk of VAMCs' noncompliance with 
these requirements, and ensure that noncompliance is addressed. 
[Footnote 27] 

Without oversight of the selected purchasing requirements, VA is 
unable to identify and address VAMCs' noncompliance with the selected 
purchasing requirements. During our site visits to six VAMCs, we 
identified examples of noncompliance with these requirements that 
created potential risks to veterans' safety.[Footnote 28] 

VAMC committee review and approval. Officials from four of the six 
VAMCs we visited told us that certain expendable medical supplies--for 
example, those used in a limited number of clinical departments--were 
sometimes purchased without the required VAMC committee review and 
approval. Furthermore, officials from one of those four VAMCs told us 
that none of the expendable medical supplies it purchased were 
reviewed and approved by a VAMC committee. Without obtaining the 
required review and approval, these VAMCs may have purchased 
expendable medical supplies without evaluating their cost-
effectiveness or likely effect on veterans' care. 

Signatures of purchasing and approving officials. At one of the six 
VAMCs we visited, VAMC officials discovered that one staff member 
working in a dialysis department purchased expendable medical supplies 
without obtaining the required signature of an appropriate approving 
official. That staff member ordered the wrong supplies, which 
incorrectly allowed blood to pass into dialysis machines. Those 
supplies were used for 83 veterans, resulting in potential cross- 
contamination of these veterans' blood, which may have exposed them to 
infectious diseases, such as HIV, hepatitis B, and hepatitis C. 
[Footnote 29] 

In January 2011, VA headquarters officials told us that they intend to 
develop an approach to oversee VAMCs' compliance with the selected 
purchasing requirements, although VA has not yet established a 
timeline for developing and implementing this oversight. In addition, 
an official from one VISN told us in January 2011 that the VISN 
planned to begin overseeing VAMCs' compliance with VA's requirement 
that two signatures be obtained for purchases of expendable medical 
supplies and RME. However, the official told us that the VISN had not 
yet established a timeline for developing and implementing this 
oversight. 

Despite Changes Intended to Improve Its Oversight of VAMCs' Compliance 
with Selected Reprocessing Requirements, VA's Oversight Has Weaknesses: 

Beginning in fiscal year 2011, VA headquarters directed VISNs to make 
three changes intended to improve its oversight of VAMCs' compliance 
with the selected reprocessing requirements at VAMCs.[Footnote 30] 

* VA headquarters recently required VISNs to increase the frequency of 
site visits to VAMCs--from one to three unannounced site visits per 
year--as a way to more quickly identify and address areas of 
noncompliance with selected VA reprocessing requirements. 

* VA headquarters also recently required VISNs to begin using a 
standardized assessment tool to guide their oversight activities. 
[Footnote 31] According to VA headquarters officials, requiring VISNs 
to use this assessment tool will enable the VISNs to collect 
consistent information on VAMCs' compliance with VA's reprocessing 
requirements. Before VA established this requirement, the six VISNs 
that oversee the VAMCs we visited often used different assessment 
tools to guide their oversight activities. As a result, they reviewed 
and collected different types of information on VAMCs' compliance with 
these requirements. 

* VISNs are now required to report to VA headquarters information from 
their site visits. Specifically, following each unannounced site visit 
to each VAMC, VISNs are required to provide VA headquarters with 
information on VAMCs' noncompliance with VA's reprocessing 
requirements and VAMCs' corrective action plans to address areas of 
noncompliance. Prior to fiscal year 2011, VISNs were generally not 
required to report this information to VA headquarters.[Footnote 32] 

Despite the recent changes, VA's oversight of VAMCs' compliance with 
its reprocessing requirements, including those we selected for review, 
has weaknesses in the context of the federal internal control for 
monitoring. Consistent with the internal control for monitoring, we 
would expect VA to analyze this information to assess the risk of 
noncompliance and ensure that noncompliance is addressed. However, VA 
headquarters does not analyze information to identify the extent of 
noncompliance across all VAMCs, including noncompliance that occurs 
frequently or poses high risks to veterans' safety. As a result, VA 
headquarters has not identified the extent of noncompliance across all 
VAMCs with, for example, VA's operational reprocessing requirement 
that staff use personal protective equipment when performing 
reprocessing activities, which is key to ensuring that clean RME are 
not contaminated by coming into contact with soiled hands or clothing. 
Three of the six VAMCs we visited had instances of noncompliance with 
this requirement. Similarly, because VA headquarters does not analyze 
information from VAMCs' corrective action plans to address 
noncompliance with VA reprocessing requirements, it is unable to 
confirm, for example, whether VAMCs have addressed noncompliance with 
its operational reprocessing requirement to separate clean and dirty 
RME. Two of the six VAMCs we visited had not resolved noncompliance 
with this requirement. Compliance with this requirement is important 
to ensure that clean RME does not become contaminated by coming into 
contact with dirty RME. 

VA headquarters officials told us that VA plans to address the 
weaknesses we identified in its oversight of VAMCs' compliance with 
reprocessing requirements. Specifically, VA headquarters officials 
told us that they intend to develop a systematic approach to analyze 
the information on VAMCs' noncompliance and corrective action plans to 
identify areas of noncompliance across all VAMCs, including those that 
occur frequently, pose high risks to veterans' safety, or have not 
been addressed in a timely manner.[Footnote 33] While VA has 
established a timeline for completing these changes, certain VA 
headquarters officials told us that they are unsure whether this 
timeline is realistic due to possible delays resulting from VA's 
ongoing organizational realignment, which had not been completed as of 
April 6, 2011.[Footnote 34] 

Conclusions: 

Weaknesses exist in VA's processes for tracking expendable medical 
supplies and RME and reprocessing RME that create potential safety 
risks to veterans. Because VA does not require VAMCs to track 
information about certain expendable medical supplies and RME in their 
inventory management systems, VAMCs may be unaware of the complete 
inventory of such items at their facilities. This knowledge is 
critical to maintain available supplies on hand to serve veterans, to 
properly identify items for which manufacturers have issued recalls, 
and to develop training on reprocessing the RME in their inventory. 
Moreover, VA's lack of specificity and conflicting guidance for 
developing device-specific training for reprocessing RME has led to 
confusion among VAMCs about which types of RME require device-specific 
training and how VAMCs should develop that training. This confusion 
has contributed to some VAMCs not developing training for their staff 
for some critical and semi-critical RME. Until these weaknesses are 
addressed, the safety of veterans receiving care at VAMCs could 
potentially be at risk. 

A general lack of oversight of VAMCs' compliance with selected 
purchasing requirements makes it difficult for VA to identify and 
resolve situations wherein items are purchased without proper review 
and approval. A failure to review and approve these purchases poses 
safety risks to veterans being treated in VAMCs. In fact, during our 
visits to VAMCs, we noted examples of expendable medical supplies that 
were purchased without appropriate review and approval. As a result, 
some supplies may have been purchased without evaluating the likely 
effect on veterans' care, or worse yet, the wrong supplies were 
ordered--a mistake that potentially led to some veterans being exposed 
to infectious diseases. Furthermore, weaknesses in oversight of VAMCs' 
compliance with the selected reprocessing requirements do not allow VA 
to identify and subsequently address areas of noncompliance across all 
VAMCs, including those that occur frequently, pose high risks to 
veterans' safety, or have not been addressed by VAMCs. Providing 
effective oversight over purchasing and reprocessing requirements 
consistent with the federal standards for internal control would help 
VA prevent potentially harmful incidents from occurring. 

Recommendations for Executive Action: 

To help ensure veterans' safety through VA's purchasing, tracking, and 
reprocessing requirements, we are making four recommendations. We 
recommend that the Secretary of Veterans Affairs direct the Under 
Secretary for Health to take the following four actions: 

* Require VAMCs to enter information about all expendable medical 
supplies and RME into an appropriate inventory management system. 

* Develop and implement an approach for providing standardized 
training for reprocessing all critical and semi-critical RME to VAMCs. 
Additionally, hold VAMCs accountable for implementing device-specific 
training for all of these RME. 

* Develop and implement an approach to oversee compliance at all VAMCs 
with the selected purchasing requirements. 

* Use the information on noncompliance identified by the VISNs and 
information on VAMCs' corrective action plans to identify areas of 
noncompliance across all 153 VAMCs, including those that occur 
frequently, pose high risks to veterans' safety, or have not been 
addressed, and take action to improve compliance in those areas. 

Agency Comments and Our Evaluation: 

VA provided written comments on a draft of this report, which we have 
reprinted in appendix II. In its comments, VA concurred with our 
recommendations and described the department's planned actions to 
implement them. VA also provided technical comments, which we 
incorporated, as appropriate. 

To address our recommendation that VA require VAMCs to enter 
information about all expendable medical supplies and RME into an 
appropriate inventory management system, VA stated that it plans to 
take several actions that include the following. By September 30, 
2011, the department plans to implement a process for tracking 
information on certain expendable medical supplies, which are 
currently not being tracked in GIP, to ensure that these items can be 
identified in the event of a recall. Furthermore, by September 30, 
2011, VA plans to implement a pilot program for tracking certain RME, 
such as surgical and dental instruments, which are currently not being 
tracked in AEMS/MERS. 

To address our recommendation that VA develop an approach for 
providing standardized training to VAMCs on reprocessing all critical 
and semi-critical RME, VA stated that it is taking several actions, 
which include revising VA's requirement for developing device-specific 
reprocessing training and providing staff training through a 
professional organization that specializes in RME reprocessing. In our 
report, we stated that VA headquarters is planning to develop device- 
specific training available to all VAMCs for certain critical and semi-
critical RME for which RME manufacturers have not developed this 
training, such as dental instruments, but had not developed a time 
frame for developing this training. VA's comments did not provide an 
update on when this training would be developed. To hold VAMCs 
accountable for implementing training for critical and semi-critical 
RME, VA reiterated that it is strengthening its oversight of VAMCs and 
is requiring VAMCs to develop corrective action plans to ensure that 
noncompliance with the training requirement is addressed. 

To address our recommendation that VA develop and implement an 
approach to oversee compliance with selected purchasing requirements 
at all VAMCs, VA stated that it plans to oversee VAMCs' purchasing 
activities, including VAMCs' compliance with our selected purchasing 
requirements. To do this, VA stated that by September 30, 2011, VA 
headquarters' Purchasing and Logistics Office will begin requiring 
VISN officials to conduct routine site visits to VAMCs to help the 
latter develop action plans for addressing noncompliance with the 
purchasing requirements. The Purchasing and Logistics Office also 
plans to review and approve these action plans and follow up with 
VAMCs to ensure that any noncompliance is addressed. 

To address our recommendation that VA use information on noncompliance 
to identify areas of noncompliance across all VAMCs and take action to 
improve compliance in those areas, VA plans to analyze the results of 
its oversight activities to identify national concerns and target 
future Sterile Processing Department initiatives. In our report we 
stated that while VA has established a timeline for conducting this 
analysis, certain VA headquarters officials told us that they were 
unsure whether this timeline is realistic. In its comments, VA did not 
provide information on whether it anticipates meeting its expected 
timeline. VA also reiterated changes that it has made that are 
intended to improve its oversight of VAMCs' compliance with its 
requirements. 

We are sending copies of this report to the Secretary of Veterans 
Affairs, appropriate congressional committees, and other interested 
parties. In addition, the report is available at no charge on the GAO 
Web site at [hyperlink, http://www.gao.gov]. 

If you or your staffs have any questions about this report, please 
contact me at (202) 512-7114 or williamsonr@gao.gov. Contact points 
for our Offices of Congressional Relations and Public Affairs are on 
the last page of this report. GAO staff who made major contributions 
to this report are listed in appendix III. 

Signed by: 

Randall B. Williamson: 
Director, Health Care: 

[End of section] 

Appendix I: Scope and Methodology: 

To examine Department of Veterans Affairs (VA) purchasing, tracking, 
and reprocessing requirements, we reviewed relevant VA policies 
[Footnote 35] and from these policies we judgmentally selected two 
purchasing requirements, two tracking requirements, and two 
reprocessing requirements that we determined were relevant to 
veterans' safety issues that were identified at certain VA medical 
centers (VAMC) in 2008 and 2009. Specifically, the purchasing 
requirements we selected were relevant to a patient safety incident at 
the VAMC in Palo Alto, California, resulting from the improper 
purchase and use of dialysis supplies; the tracking requirements we 
selected were relevant to a patient safety incident resulting from the 
improper reprocessing of endoscopy equipment at the VAMC in Miami, 
Florida; and the reprocessing requirements we selected were relevant 
to patient safety incidents resulting from the improper reprocessing 
of endoscopy equipment at the VAMCs in Augusta, Georgia; Miami, 
Florida; and Murfreesboro, Tennessee. 

After selecting these requirements for our review, we judgmentally 
selected six VAMCs at the following locations to visit: Albany, New 
York; Cheyenne, Wyoming; Detroit, Michigan; Miami, Florida; Palo Alto, 
California; and St. Louis, Missouri. These VAMCs represent different 
surgical complexity groups,[Footnote 36] serve veteran populations of 
different sizes, and are located in different Veterans Integrated 
Service Networks (VISN). (See table 1.) 

Table 1: Characteristics of VAMCs Selected for Site Visits: 

VAMC location: Albany, New York; 
Surgical complexity group[A]: 2; 
Size of patient population served, 2009: Greater than 24,999 and less 
than 50,000; 
VISN: 2. 

VAMC location: Cheyenne, Wyoming; 
Surgical complexity group[A]: 3; 
Size of patient population served, 2009: Less than 25,000; 
VISN: 19. 

VAMC location: Detroit, Michigan; 
Surgical complexity group[A]: 1c; 
Size of patient population served, 2009: Greater than 24,999 and less 
than 50,000; 
VISN: 11. 

VAMC location: Miami, Florida; 
Surgical complexity group[A]: 1b; 
Size of patient population served, 2009: Greater than 49,999; 
VISN: 8. 

VAMC location: Palo Alto, California; 
Surgical complexity group[A]: 1a; 
Size of patient population served, 2009: Greater than 49,999; 
VISN: 21. 

VAMC location: St. Louis, Missouri; 
Surgical complexity group[A]: 1a; 
Size of patient population served, 2009: Greater than 49,999; 
VISN: 15. 

Source: GAO analysis of VA data. 

[A] VA assigns each VAMC a complexity score between 1 and 3, with 
level 1 being the most complex, using a facility complexity model. 
Level 1 is broken down further into 1a, 1b, and 1c. That model uses 
multiple variables to measure facility complexity arrayed along four 
categories, namely patient population served, clinical services 
offered, education and research complexity, and administrative 
complexity. 

[End of table] 

At these six VAMCs, we examined the adequacy of the selected 
purchasing, tracking, and reprocessing requirements to help ensure the 
safety of veterans who received care. To do this, we examined how the 
requirements in these policies were implemented and whether the 
requirements indirectly created a potential risk to the safety of 
veterans who receive care at VAMCs. Specifically, at each VAMC we 
visited, we reviewed applicable VAMC committee meeting 
minutes[Footnote 37] and other documentation on the implementation of 
these requirements. We also interviewed VAMC officials who were 
responsible for implementing the selected requirements to determine 
whether the requirements were adequate to help ensure veterans' 
safety. At each VAMC, these officials included members of the 
executive leadership team, the nurse executive, the chief of the 
Sterile Processing Department, the patient safety manager, infection 
preventionists, and members of the quality management staff.[Footnote 
38] 

To examine VA's oversight of VAMCs' compliance with the purchasing, 
tracking, and reprocessing requirements we selected, we reviewed VA's 
oversight of these requirements and evaluated whether this oversight 
provides VA with adequate information to identify and address 
noncompliance. As part of this review, we reviewed VA's oversight in 
the context of federal standards for internal control for 
monitoring.[Footnote 39] The internal control for monitoring refers to 
an agency's ability to assure that ongoing review and supervision 
activities are conducted, with the scope and frequency depending on 
the assessment of risks, deficiencies are communicated to at least one 
higher level of management, and actions are taken in response to 
findings or recommendations within established timelines. 

We then interviewed officials from VA headquarters, including the 
Sterile Processing Department, the Infectious Disease Program Office, 
and the System-wide Ongoing Assessment and Review Strategy; VA's 
Office of Inspector General; and the six VISNs that oversee the VAMCs 
we visited who are responsible for overseeing compliance with VA's 
requirements, including those we selected for our review. Through our 
interviews, we obtained information on the oversight activities 
conducted by each of these entities and the extent to which these 
entities followed up with VAMCs to ensure that they corrected problems 
identified through these oversight activities. In addition, we 
obtained and reviewed relevant documents regarding VA oversight, 
including internal reports, VAMCs' plans to correct problems 
identified through oversight activities, and policy memorandums. 

We conducted this performance audit from March 2010 to May 2011 in 
accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives. 

[End of section] 

Appendix II: Comments from the Department of Veterans Affairs: 

Department Of Veterans Affairs: 
Washington DC 20420: 

April 11, 2011: 

Mr. Randall B. Williamson: 
Director, Health Care: 
U.S. Government Accountability Office: 
441 G Street, NW: 
Washington, DC 20548: 

Dear Mr. Williamson: 

The Department of Veterans Affairs (VA) has reviewed the Government
Accountability Office's (GAO) draft report, VA HEALTH CARE: Weaknesses 
in Policies and Oversight Governing Medical Supplies and Equipment 
Pose Risks to Veterans' Safety (GA0-11-391). VA generally agrees with 
GAO's conclusions and concurs with GAO's recommendations. 

The enclosure specifically addresses each of GAO's recommendations and 
provides comments on the draft report. VA appreciates the opportunity 
to comment on your draft report. 

Sincerely, 

Signed by: 

John R. Gingrich: 
Chief of Staff: 

Enclosure: 

[End of letter] 

Enclosure: 

Department of Veterans Affairs (VA) Response to Government 
Accountability Office (GAO) Draft Report: VA Health Care: Weaknesses 
in Policies and Oversight Governing Medical Supplies and Equipment 
Pose Risks to Veterans' Safety (GA0-11-391). 

GAO recommendation: To help ensure veterans' safety through VA's 
purchasing, tracking, and reprocessing requirements, we are making 
four recommendations. We recommend that the Secretary of Veterans 
Affairs direct the Under Secretary for Health to take the following 
actions: 

Recommendation 1: Require VAMCs to enter information about all 
expendable medical supplies and RME into an appropriate inventory 
management system. 

VA response: Concur. In accordance with Veterans Health Administration 
(VHA) Directive 1761.1, Standardization of Supplies and Equipment, 
dated January 26, 2001, and VHA Handbook 1761.0?, VHA Inventory 
Management, dated October 20, 2009, the Generic Inventory Package 
(GIP) Inventory System is used to maintain inventory of reoccurring 
expendable medical supplies used at VA medical centers (VAMC). All 
reoccurring expendable medical supplies, except one time use or 
specialty items used on a specific patient or procedure, are required 
to be maintained in the GIP Inventory System. All VAMCs are required 
to utilize GIP and bar code technology to monitor inventory of 
expendable medical supplies. 

For specialty items that do not meet the criteria established in the 
GIP Inventory System, VHA's Procurement and Logistics Office (PLO) 
will develop a process to capture information on such items to ensure 
that they can be identified in the event of a medical device recall. 
The anticipated completion date for development of policy guidance and 
implementation is September 30, 2011. 

PLO will also develop a plan that will restrict the use of purchase 
cards for purchasing clinical items and require all clinical 
expendable supplies to be acquired through the Facility Logistics 
Program. This will help to ensure that information on purchases of 
expendable medical supplies is reported and accounted for accurately. 
The anticipated completion date for development of policy guidance and 
implementation is September 30, 2011. 

Reusable medical equipment (RME) such as surgical and dental 
instruments do not have individual identifiers for tracking and are 
not maintained in the Automated Engineering Management System/Medical 
Equipment Reporting inventory system. In an effort to track individual 
instruments in a production management system, a pilot of the Real 
Time Location System (RTLS) will be initiated under the auspices of the
Secretary's Major Initiatives. Based on the information gained from 
the pilots, the PLO will work closely with the RTLS Program Office for 
a broader implementation plan. The anticipated completion date is 
September 30, 2011. 

In accordance with a February 11, 2011, memorandum from the Deputy 
Under Secretary for Health for Operations and Management, Veterans 
Integrated Service Network (VISN) Chief Logistics Officers must 
validate VAMC compliance with applicable directives and policies 
relating to management of expendable and non-expendable inventory by 
conducting site visits to each VAMC by April 30, 2011, and providing a 
summary report to the PLO that includes action plans to correct any 
deficiencies identified during such site visits. These site visits 
will be conducted using the revised Management Quality Assurance 
Service Checklist, dated October 1, 2010, and include the appropriate 
use of the GIP Inventory System and validation of the proper review 
and approval of items procured for use at VAMCs. The VISN Chief 
Logistics Officers will be required to follow-up and validate that 
action plans have been completed and report the results to PLO for 
review by June 30, 2011. 

Recommendation 2: Develop and implement an approach for providing 
standardized training for reprocessing all critical and semi-critical 
RME to VAMCs. Additionally, hold VAMCs accountable for implementing 
device-specific training for all of these RME. 

VA response: Concur. VHA has implemented a new inspection process that 
requires a total of nine reviews per year per facility (six performed 
by facility officials and three by VISN officials annually). A 
standardized inspection tool is being used to verify standardized 
operating procedures (SOP) and employee competencies. This 
standardized inspection tool has already been released to the field, 
is available on the SharePoint site, and is being used by both the 
facility and VISN inspection teams. The inspection tool asks questions 
targeted to address those issues that are of a higher risk to patient 
safety. The results of the inspections will be reviewed, tracked, and 
trended nationally. 

Facilities that are not in compliance, as identified by the results of 
the inspections, are required to develop action plans, which are 
reviewed and monitored by the VISN Sterile Processing Department (SPD) 
Board and by VA Central Office SPD Operations. According to VHA 
Directive 2009-031, Improving Safety in the Use of Reusable Medical
Equipment through Standardization of Organizational Structure and 
Reprocessing Requirements, the SPD Board has the "authority and 
accountability for ensuring" that reprocessing occurs in accordance 
with current manufacturers' instructions and VHA policy. 

Training of staff that reprocess RME is accomplished using 
standardized SOPs and Tech Ready Documents. VA Directive 7176, Supply 
Processing and Distribution, requires facility managers to annually 
validate competencies of staff and document this in their training 
records. All 153 facilities report through their VISN offices that 
initial training is completed and competencies are maintained on 
critical and semi-critical equipment used in their facilities. As 
staff, equipment, or manufacturer's instructions change, the training 
is updated and made available at all facilities through OneSource. 

SPD Operations has also partnered with the VHA Office of Clinical 
Consultation and Compliance (OCCC) to conduct a standardized, 
extensive educational program and maintain records of attendance 
through the International Association of Healthcare Central Services 
Material Management (IAHCSMM). IAHCSMM is an internationally 
recognized professional organization dedicated to the education and 
certification of SPD personnel. The IAHCSMM recognizes VHA Level 2 
certification as an alternate means of certification. During fiscal 
year (FY) 2010, VHA's own Level 2 training was revised to include a 
standardized curriculum and certification examination. During FY 2010, 
four Level 2 classes were offered and attended by more than 200 SPD 
professionals and managers. VA employees are being encouraged to apply 
for this alternate IAHCSMM certification. 

Training requirements in the current VA Directive 7176 are being re-
written to include extensive requirements for training and 
verification of competencies for staff reprocessing RME. This 
directive is currently in draft form and being reviewed for content by 
a group of field-based and national SPD experts and managers. It will 
enter VA's formal concurrence process on or before April 30, 2011, 
with an expected publication date of September 30, 2011. 

Recommendation 3: Develop and implement an approach to oversee 
compliance at all VAMCS with the selected purchasing requirements. 

VA response: Concur. GAO selected two specific purchasing requirements 
for review. The first requirement establishes processes for committee 
review and approval, and the second requires specific signatures for 
approval. To address these specific purchasing requirements, as well 
as to establish a uniform approach to ensure appropriate review and 
approval of all new items utilized at VAMCs, the Deputy Under 
Secretary for Health for Operations and Management in January 2011 
directed all VISNs to establish Network Commodity Standardization 
Committees. The new Committees will ensure that items to be purchased 
are first reviewed and approved before they are used at a facility. 

PLO also is establishing a Program Executive Office (PEO) that 
includes an Operations/Policy Division to provide oversight and 
support of VHA facility purchasing activities, including compliance 
with appropriate VHA directives and policies, including those selected 
by GAO in its review. PLO will develop a compliance review process to 
ensure routine site visits are performed at each VAMC by VISN 
Logistics Office staff. A site visit report and corresponding action 
plan will be developed for each site visit and forwarded to PLO for 
review and approval. PLO will perform follow-up reports to ensure all 
action items are implemented and closed out. The anticipated 
completion date is September 30, 2011. 

Further, to ensure VAMC compliance with the use of mandatory national 
standardized contracts, the PEO will establish management controls to 
ensure that VHA program offices are included in the development of 
contract requirements and solutions to improve compliance with 
selected purchasing requirements. The anticipated completion date is 
September 30, 2011. 

Recommendation 4: Use the information on noncompliance identified by 
the VISNs and information on VAMC's corrective action plans to 
identify areas of noncompliance across all 153 VAMCs, including those 
that occur frequently, pose high risk to veterans' safety, or have not 
been addressed, and take action to improve compliance in those areas. 

VA response: Concur. As noted in the response to Recommendation 2, 
facility and VISN officials will conduct an increased number of 
inspections to ensure proper reprocessing of RME. The results of these 
inspections will be reviewed, tracked, and trended nationally to 
identify national concerns and target future SPD initiatives. 

The Office of Deputy Under Secretary for Operations and Management, SPD
Operations, is developing a standardized tool to aggregate the 
information from the standardized VISN and/or facility inspection 
results. This tool will assist in identifying any common deficiencies 
or areas nationwide where additional training of staff that performs 
reprocessing may be required. This tool will be deployed nationwide on 
or before September 30, 2011. VISNs will also be required to identify 
specific deficiencies at facilities and develop action plans that will 
be tracked by the VISN SPD board in order to improve compliance at the 
facility level. The anticipated completion date is September 30, 2011. 

Staff from the Office of Deputy Under Secretary for Operations and 
Management, SPD Operations, will continue to perform site visits to 
provide additional oversight to ensure that annual training and 
competency assessments are completed. During FY 2010, a total of 22 
site visits were performed, and to date in FY 2011, a total of eight 
site visits have been performed with a total of 18 pending visits 
prior to the end of FY 2011. The staff from SPD Operations will use 
the same standardized inspection tool as the VISN and facility to 
ensure equal comparisons of information and deficiencies are 
identified. 

[End of section] 

Appendix III: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Randall B. Williamson, (202) 512-7114 or williamsonr@gao.gov: 

Staff Acknowledgments: 

In addition to the contact named above, Mary Ann Curran, Assistant 
Director; David Barish; Kye Briesath; Alana Burke; Melanie Krause; and 
Michael Zose made key contributions to this report. Lisa Motley 
provided legal support and Krister Friday assisted in the message and 
report development. 

[End of section] 

Footnotes: 

[1] The management of VAMCs is decentralized to 21 VISNs. 

[2] See, for example, VA Handbook 7176, Supply, Processing, and 
Distribution (SPD) Operational Requirements (Aug. 16, 2002) and 
Veterans Health Administration (VHA) Handbook 1761.02, VHA Inventory 
Management (Oct. 20, 2009). 

[3] VA Handbook 7176, Supply, Processing, and Distribution (SPD) 
Operational Requirements; VHA Directive 2009-004, Use and Reprocessing 
of Reusable Medical Equipment (RME) in Veterans Health Administration 
Facilities (Feb. 9, 2009); and VHA Directive 2009-031, Improving 
Safety in the Use of Reusable Medical Equipment Through 
Standardization of Organizational Structure and Reprocessing 
Requirements (June 26, 2009). 

[4] According to press articles, patient safety incidents involving 
improperly reprocessed RME have also occurred at non-VA hospitals. For 
example, a Pittsburgh Tribune-Review article from September 16, 2009, 
noted that patients at a non-VA hospital in Pennsylvania were 
potentially exposed to infectious diseases due to the improper 
reprocessing of surgical instruments. See W.F. Roche, "UPMC's Venango 
County facility improperly sterilized equipment," TribLIVE News (Sept. 
16, 2009). Accessed on February 16, 2011, at [hyperlink, 
http://www.pittsburghlive.com/x/leadertimes/s_643419.html]. 

[5] See M. Owens, "St. Louis VA Medical Center dental infections: 
Nearly 2,000 at risk," KSDK.com (June 29, 2010). Accessed on February 
16, 2011, at [hyperlink, 
http://www.ksdk.com/news/local/story.aspx?catid=3&storyid=205262]. 

[6] We reviewed applicable VA policies, including VHA Handbook 
1761.02, VHA Inventory Management; VHA Directive 2009-031, Improving 
Safety in the Use of Reusable Medical Equipment Through 
Standardization of Organizational Structure and Reprocessing 
Requirements; VHA Directive 2009-004, Use and Reprocessing of Reusable 
Medical Equipment (RME) in Veterans Health Administration Facilities; 
VA Handbook 7002, Logistics Management Procedures (July 10, 2009); VA 
Handbook 7176, Supply, Processing, and Distribution (SPD) Operational 
Requirements; and VA Standard Operating Procedure #AM 5, Inventory of 
Equipment in Use Standard Operating Procedure (Feb. 17, 2011). 

[7] VA assigns each VAMC a complexity score between 1 and 3, with 
level 1 being the most complex, using a facility complexity model. 
Level 1 is broken down further into 1a, 1b, and 1c. That model uses 
multiple variables to measure facility complexity arrayed along four 
categories, namely patient population served, clinical services 
offered, education and research complexity, and administrative 
complexity. 

[8] Each of the six VAMCs we visited is located within a different 
VISN. 

[9] We reviewed minutes from the following committees: commodity 
standards, equipment, medical executive, infection control, and RME. 

[10] See GAO, Standards for Internal Control in the Federal 
Government, [hyperlink, 
http://www.gao.gov/products/GAO/AIMD-00-21.3.1] (Washington, D.C.: 
November 1999) and GAO, Internal Control Management and Evaluation 
Tool, [hyperlink, http://www.gao.gov/products/GAO-01-1008G] 
(Washington, D.C.: August 2001). 

[11] 38 U.S.C. §§ 1710(a)(1)-(3), 1701(5), (6). Requirements for VA 
health care services are effective in any fiscal year only to the 
extent and in the amount provided in advance in appropriations acts 
for such purposes. 38 U.S.C. § 1710(a)(4). 

[12] See 38 C.F.R. § 17.37 (2010). 

[13] Generally, a VAMC's commodity standards committee reviews and 
approves purchases of expendable medical supplies and a VAMC's 
equipment committee reviews and approves purchases of RME. 

[14] See VA Handbook 7176, Supply, Processing, and Distribution (SPD) 
Operational Requirements. 

[15] VA Handbook 7002, Logistics Management Procedures. 

[16] According to VHA Handbook 1730.01, Use and Management of the 
Government Purchase Card Program (Aug. 27, 2008), purchases are 
defined as recurring if they are made four or more times per year. In 
contrast, VHA Handbook 1761.02, VHA Inventory Management, states that 
expendable medical supplies that are ordered on a recurring basis must 
be entered into GIP but does not specify the number of times per year 
a purchase must be made in order to qualify as recurring. 

[17] Nonexpendable equipment has a life expectancy of 2 years or more. 
See VA Standard Operating Procedure #AM 5, Inventory of Equipment in 
Use Standard Operating Procedure and VA Handbook 7002, Logistics 
Management Procedures. 

[18] See VA Handbook 7176, Supply, Processing, and Distribution (SPD) 
Operational Requirements, VHA Directive 2009-004, Use and Reprocessing 
of Reusable Medical Equipment (RME) in Veterans Health Administration 
Facilities, and VHA Directive 2009-031, Improving Safety in the Use of 
Reusable Medical Equipment Through Standardization of Organizational 
Structure and Reprocessing Requirements. 

[19] See GAO, VA Health Care: Preliminary Observations on the 
Purchasing and Tracking of Supplies and Medical Equipment and the 
Potential Impact on Veterans' Safety, [hyperlink, 
http://www.gao.gov/products/GAO-10-1038T] (Washington, D.C.: Sept. 23, 
2010). 

[20] Officials from this VAMC also checked with staff responsible for 
reprocessing in the gastrointestinal department, which is where 
colonoscopies are performed, to determine whether the VAMC possessed 
this type of RME. See VA Office of Inspector General, Use and 
Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical 
Facilities, 09-01784-146 (Washington, D.C.: June 2009). 

[21] As of August 17, 2010, the VAMC reported that it has successfully 
notified 2,523 of the 2,526 veterans of possible exposure to 
infectious diseases and that there were 17 new positive test results. 
VA reports that these results are not necessarily linked to RME issues 
and it is continuing its evaluation. 

[22] According to VA headquarters officials, certain RME are difficult 
to reprocess because they need to be fully disassembled in order to be 
reprocessed correctly, so developing device-specific training for 
reprocessing these items is important to help ensure veterans' safety. 

[23] RME is generally categorized into critical, semi-critical, or non-
critical items based on the degree of risk for infection involved in 
use of the item. Critical items, such as surgical instruments, are 
those that enter sterile tissue or the vascular system and require 
sterilization because they confer a high risk of infection. Semi- 
critical items, such as certain endoscopes, are those that contact 
mucous membranes or non-intact skin and minimally require high-level 
disinfection. Non-critical items, such as wheelchairs, are those that 
come into contact with intact skin and may be cleaned with low-level 
disinfectants. 

[24] VA officials stated that manufacturer guidelines for reprocessing 
RME may be technically complex and may include steps that VAMCs are 
unable to follow. For example, these officials stated that guidelines 
from RME manufacturers may require the use of a specific disinfectant 
that is not available in the United States. The Food and Drug 
Administration has responsibility for overseeing RME, including the 
guidelines written by manufacturers for reprocessing these items. 

[25] VA headquarters' Management Quality Assurance Service (MQAS) 
oversees each VAMC's compliance with the selected VA tracking 
requirements approximately once every 7 to 8 years as part of broader 
compliance reviews. MQAS uses a standardized checklist to conduct 
these reviews. Following each review, VAMCs are required to develop 
corrective action plans to address areas of noncompliance. MQAS 
subsequently analyzes information on VAMC noncompliance and corrective 
action plans to identify the extent of noncompliance across all VAMCs, 
including those that occur frequently or have not been resolved. 
Although we did not identify any weaknesses in VA's oversight of the 
selected tracking requirements, as described earlier in this report, 
we did identify inadequacies in those requirements that pose risks to 
the safety of veterans. 

[26] VA policy requires VISNs to conduct annual audits of some 
purchases--those made using purchase cards--which may include 
examining whether the two required signatures were obtained. However, 
according to a VA headquarters official, these audits are conducted 
inconsistently across VISNs. See VHA Handbook 1730.01, Use and 
Management of the Government Purchase Card Program. 

[27] The federal internal control for monitoring states that an agency 
should be able to ensure that ongoing review and supervision 
activities are conducted, with the scope and frequency depending on 
the assessment of risks, and that actions in response to findings or 
recommendations are taken within established timelines. See 
[hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1] and 
[hyperlink, http://www.gao.gov/products/GAO-01-1008G]. 

[28] We previously reported examples of noncompliance with selected VA 
purchasing and tracking requirements from five VAMCs we visited. See 
GAO-10-1038T. We have since conducted a site visit to a sixth VAMC. 

[29] As of June 2, 2010, the VAMC reported that all testing has been 
completed and that no veterans have acquired infectious diseases as a 
result of this incident. The VAMC found that 1 of the 83 veterans 
identified was dialyzed on an uncontaminated machine and therefore 
this veteran was not notified or tested for these infectious diseases. 

[30] VA headquarters generally delegates responsibility for this 
oversight to the VISNs. In addition to oversight conducted by the 
VISNs, some entities within VA headquarters conduct oversight of 
VAMCs' compliance with VA reprocessing requirements, including those 
we selected for review. Specifically, VA's OIG and Sterile Processing 
Department conduct site visits to investigate allegations of VAMC 
noncompliance with VA reprocessing requirements. In addition, since 
around 2005, the System-wide Ongoing Assessment and Review Strategy 
has included reviews of the selected VA reprocessing requirements as 
part of broader reviews of VAMC compliance with VA policies in 
preparation for external accreditation reviews approximately every 3 
years. In 2010, VA's OIG also conducted reviews of the selected VA 
reprocessing requirements as part of broader ongoing reviews of VAMC 
compliance with VA policies. 

[31] VA headquarters officials told us that they may refine this 
assessment tool over time. 

[32] While VISNs were not generally required to report to VA 
headquarters information on VAMCs' noncompliance with VA's 
reprocessing requirements, VISNs were required to report to VA 
headquarters information about noncompliance that may have resulted in 
harm to veterans. VA headquarters officials told us that, following a 
review of that information and collection of additional information, 
as needed, a panel of experts would determine whether the 
noncompliance identified in the reviews resulted in risks to veterans' 
safety and, if so, whether veterans should be notified. See VHA 
Directive 2008-002, Disclosure of Adverse Events to Patients 
(Washington, D.C.: Jan. 18, 2008). 

[33] VA headquarters officials also told us that a temporary staff 
member was assigned in March 2011 to begin reviewing some information 
from VISNs' oversight activities. Specifically, that staff member will 
be responsible for reviewing whether VAMCs have developed the required 
device-specific training for reprocessing RME and the extent to which 
VAMCs are utilizing flash sterilization, a sterilization technique 
that should be used only in limited circumstances. 

[34] As part of this realignment, VA headquarters is establishing a 
new position within the Office of the Deputy Under Secretary for 
Health for Operations and Management, which will be responsible for 
overseeing certain departments, including VA headquarters' Sterile 
Processing Department. 

[35] We reviewed applicable VA policies, including VHA Handbook 
1761.02, VHA Inventory Management (Oct. 20, 2009); VHA Directive 2009- 
031, Improving Safety in the Use of Reusable Medical Equipment Through 
Standardization of Organizational Structure And Reprocessing 
Requirements (June 26, 2009); VHA Directive 2009-004, Use and 
Reprocessing of Reusable Medical Equipment (RME) in Veterans Health 
Administration Facilities (Feb. 9, 2009); VA Handbook 7002, Logistics 
Management Procedures (July 10, 2009); VA Handbook 7176, Supply, 
Processing and Distribution (SPD) Operational Requirements (Aug. 16, 
2002); and VA Standard Operating Procedure #AM 5, Inventory of 
Equipment in Use Standard Operating Procedure (Feb. 17, 2011). 

[36] VA assigns each VAMC a complexity score between 1 and 3, with 
level 1 being the most complex, using a facility complexity model. 
Level 1 is broken down further into 1a, 1b, and 1c. That model uses 
multiple variables to measure facility complexity arrayed along four 
categories, namely patient population served, clinical services 
offered, education and research complexity, and administrative 
complexity. 

[37] We reviewed minutes from the following committees: commodity 
standards, equipment, medical executive, infection control, and 
reusable medical equipment (RME). 

[38] The patient safety manager is responsible for overseeing the 
response to patient safety advisories and alerts from VA headquarters 
and for addressing patient safety incidents at the VAMC; infection 
preventionists are responsible for helping to ensure that infection 
control standards are followed by VAMC staff; and the quality 
management staff is responsible for monitoring the quality of care at 
VAMCs. 

[39] See GAO, Standards for Internal Control in the Federal 
Government, [hyperlink, 
http://www.gao.gov/products/GAO/AIMD-00-21.3.1] (Washington, D.C.: 
November 1999) and GAO, Internal Control Management and Evaluation 
Tool, [hyperlink, http://www.gao.gov/products/GAO-01-1008G] 
(Washington, D.C.: August 2001). 

[End of section] 

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